All industry professionals, regardless of functional roles, will benefit from this training, especially if you are involved in the day-to-day activities associated with your organization’s product development or manufacturing operations. The application of risk management is a salient requirement needed for introducing medical devices that are safe and effective in their intended use.
For organizations that introduce finished medical device into the EU, EN ISO 14971:2012 is considered a Harmonized Standard. Although the use of Harmonized Standards is strongly recommended in the EU, it is nearly an impossible task to gain product application approvals without evidence of compliance with EN ISO 14971:2012. In the United States, the FDA recognizes ISO 14971:2007 as a Consensus Standard.
The application of risk management, although clearly focused on product development, is really applicable throughout the entire product lifecycle. There are many nuances associated with the effective application of 14971; however, there are three salient elements associated with risk management that need to be clearly understood: (a) the Risk Management Plan; (b) the Risk Management File; and (c) the Risk Management Report. When properly employed during product development, risk management tools are vital in support of the design and development of finished medical devices that are safe and effective in their intended use.
Areas to be Covered:
General requirements for risk management
The risk management process
Qualifications of Personnel
The Risk Management Plan (RMP) and the Risk Management File (RMF)
Elements of risk analysis
The evaluation of risk
Elements of risk control
Evaluation of residual risk
Risk Management Report (RMR)
Production and post-product information
Who will Benefit: